BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    UROTRACK PLUS

    K Number: K832526 · Decision Sep 19, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    9
    Review Days
    52

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    Basic Information

    Device Name
    UROTRACK PLUS
    K Number
    K832526
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Vital Metrics, Inc.
    Date Received
    July 29, 1983
    Decision Date
    September 19, 1983
    Product Code
    KNX
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNX Collector, Urine, (And Accessories) For Indwelling Catheter

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    Other Clearances by Vital Metrics, Inc.

    K Number Device Name
    K883201 VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS
    K882956 VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATION
    K844973 IRRIGA SUC ILLUM ISIS 710 & 7100 SERIES
    K843441 URINARY DRAINAGE CONTAINER 2012-WITH
    K843442 URINARY DRAINAGE CONTAINER 2013 WITH
    K840917 URINARY MONITORING SYS 240
    K834448 URINARY DRAINAGE CONTAINER
    K813641 VITAL METRICS URINE MONITORING SYSTEM